TheraP

“We're delighted to partner with the Prostate Cancer Foundation of Australia (PCFA) to launch this important study for the treatment of men with advanced prostate cancer. Clinical trials like this are the only way we can find out how well new treatments work, whether they are safe, and whether they should become the new gold standard for treatment in the future." – ANZUP Chair, Professor Ian Davis

TheraP Trial

Lutetium-177 PSMA radionuclide therapy (Lu-PSMA) is a new treatment for advanced prostate cancer. Lu-PSMA is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues. Previous small studies of Lu-PSMA showed promising activity in patients with advanced prostate cancer.

This randomised study will compare Lu-PSMA with a type of chemotherapy called cabazitaxel, which is the standard treatment for advanced prostate cancer when other treatments have stopped working. Half the participants will receive Lu-PSMA and half will receive cabazitaxel. This study will provide further information about the risks and benefits of Lu-PSMA compared with cabazitaxel in men with prostate cancer. We plan to enrol 200 participants in the study in Australia.

TheraP is a partnership between ANZUP Cancer Trials Group and the Prostate Cancer Foundation of Australia (PCFA) with support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte, It’s a Bloke Thing, Movember and CAN4CANCER.

Many prostate cancers have a substance on their cell surface called prostate specific membrane antigen (PSMA). Lu-PSMA is a radioactive molecule that, after injection into a vein, specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread and to attack those cancer cells.

Will this trial be suitable for anyone with prostate cancer?

No. This trial is aimed specifically at men with prostate cancer that has spread to other parts of the body and has continued to grow despite standard treatment (including hormonal treatment and previous docetaxel chemotherapy), and where you and your doctor have agreed that the next best step is treatment with another chemotherapy drug called cabazitaxel.

What is the aim of this trial?

The purpose of this study is to compare Lu-PSMA with cabazitaxel for men with prostate cancer that has spread to other parts of the body and has continued to grow despite standard treatment, including hormonal treatment and previous docetaxel chemotherapy. We want to know how Lu-PSMA compares against cabazitaxel in terms of shrinking the cancer, improving pain, delaying the time until the cancer grows again, effects on quality of life, safety, and how long men survive after the treatment.

It is possible that other sites may also join the trial at a later stage.

What is the expected duration of the trial?

We expect the trial to enrol participants for approximately 18 months to two years. We will then continue to follow up with these men to assess how they are doing.

I have had previous docetaxel (also referred to as Taxotere) chemotherapy, am I still eligible for this study?

Yes, you must have already received treatment with docetaxel chemotherapy to be eligible for this study. However, the trial might not be suitable for everyone who has docetaxel so you will still need to discuss this with your doctor.

I have previously had Cabazitaxel chemotherapy, am I still eligible for this study?

No, if you have previously been treated with cabazitaxel you are not eligible for this trial as cabazitaxel is being used as a comparison treatment to Lu-PSMA. Please speak to your treating team to see what other options are available to you.

Will everyone in this study receive Lutetium?

No. This is a randomised controlled study. We do not know which of these treatments is best for men in this situation. Randomisation means that trial participants are put randomly into one group or the other, so that the only major difference between the two groups is the type of treatment they receive. We then compare the outcomes of the two groups to see if one is better. In this trial, half of the participants will receive Lu-PSMA and half will receive cabazitaxel. The trial is not “blinded,” which means that you and your treating team will know which treatment you receive, but we do not get to choose which treatment you will get. There is no “placebo” or inactive treatment in this trial: everyone involved in the trial will receive a treatment that we know has a chance of helping them, although we cannot guarantee that you will receive a benefit whichever treatment you receive.

Will Lu-PSMA be available outside of the clinical trial?

We are not able to provide Lu-PSMA outside the clinical trial. It is possible it may be available elsewhere but at the moment it is still an unproven treatment.

I think this trial might be suitable for me, what should I do next?

The best thing for you to do at the moment would be to continue under the care of your cancer specialist and discuss your personal circumstances with them.

This page will be updated as more information becomes available. Please continue to refer to our website for current information.